A variety of patients populate the cohort of those at increased risk for the development of chronic lower extremity ulcerations. Among these are patients having impaired microcirculation to the lower extremities secondary to disease, e.g. diabetes, autoimmune diseases which attack the endothelium, Raynaud's disease, etc.; those patients suffering from decreased circulation due to cardiac insufficiency, for example congestive heart failure, those patients suffering a reduction in arterial perfusion due to abnormally high venous pressure and edema; and those who have suffered trauma to the lower extremities as a result of surgery or accident.
A common problem with all such patients is difficulty in the healing process. Due to the decreased perfusion of oxygenated blood, tissue breakdown occurs and ultimately results in the formation of ulcers. Of particular concern is the formation of decubitus ulcers of the heel, which are especially refractory to treatment due to the difficulty in removing contact pressure from the heel area. Whether walking about, wearing shoes and stockings, or merely lying in bed, the heel maintains virtually constant physical contact with an adjacent surface, e.g. a shoe, a stocking, a bed sheet or a footstool.
Medical professionals counsel their patients that healing of such ulcerations requires both elevation of the extremity and isolation of the wound area from the trauma of physical contact. Elevation is necessary for mediating chronic edema and abnormally high venous pressure, thereby encouraging an increase in the perfusion of oxygenated arterial blood flow to the area. Isolation of the area from physical contact promotes healing by reducing surface trauma and further debriding of the area due to friction. Isolation is also important since it allows medications to remain on the dermal and epidermal tissues thus reducing the incidence of infection.
Various apparatus have been used in an effort to accomplish the goals of isolation and elevation of the lower extremity, e.g. variously shaped foam pillows, stools, and slings or similar devices which wrap around the area allowing it to be hung from an overlying support. All of these devices have inherent drawbacks which result in a lack of compliance and increased morbidity. For example, pillows slip and change position and fall away or are pushed aside by the patient. Propping the extremity on a stool or similar device, or alternatively hanging the extremity in a sling leads to the manifestation of secondary problems, since there is always an area adjacent to the wound site which experiences increased pressure and physical trauma due to the device itself.
Thus, the prior art lacks a device which has the ability to provide elevation of a lower extremity, is capable of isolating a wound site from physical trauma, and is designed to maximize compliance and thereby increase the likelihood of a favorable outcome.